Seminar on

DEFECTS IN TABLETS
BY
ARJUN NARALA
M.PHARMACY, I SEM
DEPARTMENT OF PHARMACEUTICS
UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES
KAKATIYA UNIVERSITY
WARANGAL.

CONTENTS
Introduction
Defects in Tablets
Defects in sugar coated tablets
Defects in film coated tablets
Conclusion
References

INTRODUCTION
In the normal process of developing formulations,

and in the routine manufacture of tablets, various

defects are observed. Sometimes, the source of the
problem or the defect is the formulation, the
compression equipment, or a combination of the two.
Some defects are noticed immediately during
manufacturing but others may be noticed during
storage as in the case of capping.

DEFECTS IN TABLETS
CAPPING AND LAMINATION
PICKING AND STICKING
MOTTLING
DOUBLE IMPRESSIONS
BLACK SPECKS
CHIPPING AND SPLITTING

CAPPING AND LAMINATION

Capping is defined as the partial or complete separation of the

top or bottom crowns of a tablet from the main body of the

tablet.
Lamination is the separation of a tablet into two or more
distinct layers.
These processing problems are readily apparent immediately
after compression or may occur hours or even days later.
Subjecting tablets to the friability test is the quickest way of
revealing such problems.

CAPPING AND LAMINATION

CAUSES AND CORRECTIVE ACTIONS

Air entrapment
Reduce press speed
Precompress granulation
Reduce quantity of fine particles in the granulation
Taper dies
Ensure that punch-to-die clearance is correct
Excessive pressure
Reduce tablet weight and/or increase its thickness within

allowable tolerances
Adjust pressure

CAUSES AND CORRECTIVE ACTIONS

Too rapid expansion of tablet upon ejection
Taper dies
Poor granulation
Increase quantity of binder; use strong binder
Excessively dry granulation
Increase lubricant
Excessive lubrication of granulation
Decrease lubricant; blend all ingredients before adding

lubricant

CAUSES AND CORRECTIVE ACTIONS

Punch cavity too deep
Use punches with less concave depth
Punch tips worn
Refurbish or replace punches
Lower punch set too low at tablet take-off
Set lower punch tip flush with top of die
Tablet take-off bar set too high
Adjust take-off bar

PICKING AND STICKING

Picking refers to a tablet material

being removed from the tablets

surface by a punch.
It is of particular concern when
punch tips have engraving or
embossing.
Tablet materials adhering to
punches can accumulate to the
point of obliterating the tip design.
Sticking refers to a tablet material
adhering to the die wall.
It results in the buildup of material
on punch faces.

CAUSES AND CORRECTIVE ACTIONS

Excessive moisture
Check moisture content of granulation; drying
Check room humidity
Presence of low-melting-point substances
Dilution with higher-melting-point materials
Insufficient compaction force
Reduce tablet weight and/or increase its thickness within
allowable tolerances
Inadequate lubrication of granulation
Check and/or adjust level of lubricant used

CAUSES AND CORRECTIVE ACTIONS

Punch face condition: pits on punch faces and/or improper

draft on embossing
Try repolishing punch faces
Try chrome-plating of punch faces
Poor embossing design
Redesign embossing per TSM guidelines, or consult tooling

supplier

MOTTLING
Unequal distribution of color on a tablet, with light or dark
areas standing out in an otherwise uniform surface.
Causes and corrective actions:
Drug whose color differs from the tablet excipients or a drug
whose degradation products are colored.
Use of colorants
Migration of dyes to the surface of granulation during drying
Change the solvent system
Reduce the drying temperature
Grind to a small particle size

CAUSES AND CORRECTIVE ACTIONS

High moisture content of granulation
Dry granulation
Oversized granulation particles
Reduce particle size
Contamination of granulation, usually by grease or oil
Check oil seals on upper punch guides
Fit oil/dust caps to upper punches
Reduce lubrication of upper punches to an acceptable level
Contamination of granulation from chutes or feed hoppers
Clean and reset components correctly

DOUBLE IMPRESSION
This problem is encountered with punches that have a

monogram or other engraving on them.

Causes and corrective actions:
Rotation of punches
Adjust antiturning devices
Use keyed punches

DIRT IN PRODUCT (BLACK SPECKS) :

Dust,dirt,or press lubrication in the granulation
Clean press more frequently
Excessive or wrong press lubrication
Use proper punch dust caps
Rubbing of feeder components

CHIPPING OR SPLITTING
Poor surface finish on punch tips; worn punches and dies
Poor tooling design (e.g., sharp embossing or bisect lines)
Polish punch tips; replace punches and dies

DEFECTS IN SUGAR COATED TABLETS

CHIPPING OF COATINGS:
Sugar coatings are inherently brittle and thus prone to chipping if
mishandled.
Excessive use of insoluble fillers and pigments tends to increase
the brittleness of sugar coatings.
Avoid them where ever it is possible
Addition of small quantities of polymers(such as
cellulosics,polyvinylpyrrolidine,acacia,or gelatin) to improve
structural integrity.

CRACKING OF COATINGS:
Tablet cores that expand, either during or after coating, are likely

to cause the coating to crack.

Such expansion may result from
1.Moisture absorption by the tablet core.
2.By stress relaxation of the core after compaction.
Moisture sorption can be minimized by appropriate use of seal
coat.
Expansion due to post compaction stress relaxation can be
resolved by extending the time between the compaction event
and commencement of sugar coating.

TWINNING (OR BUILD OF MULTIPLES)

By

their very nature, sugar-coating

formulations are very sticky, particularly as
they begin to dry, and allow adjacent tablets
to stick together.
Build up of multiples really becomes a
problem when the tablets being coated have
flat surface which can easily come into
contact with one another.
Troublesome with high-dose, capsule-shaped
tablets that have high edge walls.
Appropriate choice in tablet punch design
can be effectively used to minimize the
problem.

UNEVEN COLOR
Uneven distribution of color, particularly with the darker colors,

is often visually apparent, and thus a major cause of batch

rejection.
Poor distribution of coating liquids during application
Uniform mixing of tablets in the coating process
Addition of sufficient coating liquids
Color migration of water-soluble dyes while the coating is drying
Change the solvent system
Reduce the drying temperature
Grind to a small particle size

 Unevenness of the surface of the subcoat

Achieve desired surface smoothness
Washing back of pigment-colored color coatings
Replace aluminium lakes
Use combinations of dyes and pigments
Excessive drying between color applications
Reduce rate of drying
Reduce drying temperature

BLOOMING AND SWEATING

Residual moisture in finished sugar-coated tablets can often be a
problem. over a period of time, this moisture can diffuse out and
affect the quality of the product.
Moderate levels of moisture egress cause the polish of the product to
take on a fogged appearance, a phenomenon often termed blooming.
At higher levels of moisture egress, the moisture may appear like
beads of perspiration on the tablet surface, a phenomenon often
termed sweating.
Sweating can be much more serious, since tablets stored in closed
containers will ultimately stick together.
Obtain appropriate levels of moisture.

MARBLING

To achieve a high-quality, sugar coated product it is important

to ensure that color is uniformly distributed in the color layer,

and at the end of the application of the color coating that a
smooth coating surface is obtained.
Failure to achieve the requisite smoothness often results in a
marbled appearance on polishing.
This problem occurs as the result of the collection of wax in
the small surface depressions of a rough coating and is
particularly evident with darker colors.
Check for smooth surface at the end of color coating.

DEFECTS IN FILM COATED TABLETS

PICKING:
It results when the coating on two adjacent tablets is not
sufficiently dry before contact between them occurs.
As the partially dried coating is extremely tacky, once the two
tablets make contact they adhere to one another.
Once the coating has dried they break apart later under the
influence of attrition.
In extreme cases the tablets may become permanently glued
together so that twinning occurs.
Over wetting typically occurs when the spray rate is excessive
for the drying conditions in the process.

Adjust the spray rate

Adjust the temperature of drying
Check for the proper functioning of the spray guns
Certain types of coating formulations(e.g., those based on

hydroxypropylcellulose, and several of the acrylic aqueous

latex coating systems) are inherently tackier during
application.
Replace with other polymer systems.

ORANGE PEEL(ROUGHNESS)
Inadequate spreading of the coating solution

before drying causes a bumpy or orange-peel

effect on the coating.
This indicates that spreading is impeded by
too rapid drying or by high solution viscosity.
This is caused by process conditions which
include low spray rates coupled with
excessive drying conditions and use of
excessive atomizing air pressures.
Adjust the spray rate and drying conditions
Coating liquids with high viscosities
Thinning the coating solution with additional
solvents
In brief optimize the coating process.

EDGE WEAR(CHIPPING)
Tablet edges are often exposed to

attritional effects, so fracture at

this point results in parts of the
surface being exposed, referred
as chipping.
Seen with brittle film coatings
that offer insufficient protection
to tablet edges.
Addition of small quantities of
polymers(such
as
cellulosics,polyvinylpyrrolidine,
acacia,or gelatin) to improve
structural integrity.

FILM CRACKING
Cracking of film coating occurs when the internal stress

exceeds the tensile strength of the coating.

The problem is exacerbated when significant differences exist
between the thermal expansion coefficients for the core and
coating.
Totally unacceptable for products where the applied coating is
a major factor in modifying drug-release characteristics.
Minimize the internal stresses by adjusting the plasticizer type,
pigment type and their concentration.
Increase the tensile strength of the film by using high
molecular-weight polymers or polymer blends.

FILM PEELING
During

application of aqueous
coating formulations, cohesive
failure(cracking) of the coating
occurs.
This coating may peel back from
the surface of the substrate and
result in peeling.
Cohesive and adhesive failure( both
linked to internal stress)
Increase the tensile strength of the
film
Decrease the internal stress

BRIDGING OF LOGOS(INTAGLIATIONS)
This

phenomenon occurs when a

component of the internal stress becomes
sufficiently high so as to cause partial or
complete detachment of the coating
( from the substrate) in the region of logo.
As a result of such detachment, the film is
able to shorten and thus partially relieve
the stress within the film.
This defect can be so severe that the
monogram or bisect is completely
obscured.
Improve film adhesion by adjusting
plasticizer content
Appropriate design of tablet punches with
respect to logo

IN-FILLING OF LOGOS
In-filling of logos typically occurs during the spray application

of aerated aqueous film-coating solutions.

When a foamy coating solution impinges on a regular part of
the tablet surface it will, under the shear forces generated, form
a film with normal characteristics.
Those droplets of coating liquid that reside in the logo, being
protected from shear forces at the surface, gradually dry to
form a solid foam that eventually obliterates the bisect.
Judicious monitoring of the fluid application rate and thorough
mixing of the tablets in the pan prevent filling.

BLISTERING
When coated tablets require further drying in ovens, too rapid

evaporation of the solvent from the core and the effect of high
temperature on the strength, elasticity, and adhesion of the film
may result in blistering.
Use milder drying conditions.

CONCLUSION
Tablets are widely used dosage forms but defects in

aesthetic appearance may lead to the rejection of their

administration by the patient.
From the manufacturer point of view these defects may
lead to reworking or rejection of the batch.
Although many of these defects may be purely cosmetic
some of them are totally unacceptable.
So a proper attention by the manufactuer on the source of
defects and their orderly corrections is required.

REFERENCES
Herbert A. Lieberman, Leon Lachman, Joseph B. Schwartz,

Pharmaceutical dosage forms : Tablets, Second Edition,vol 3.

Herbert A. Lieberman Leon Lachman, Theory and Practice of
Industrial Pharmacy, 2009.
James Swarbrick, James C. Boylan, Encyclopedia of
Pharmaceutical technology, Volume 15, 1996.
James Swarbrick, Encyclopedia of Pharmaceutical technology,
Third Edition, Volume 6, 2007.
Website:
www.pharmainfonet.com

THANK YOU